Functional Constipation (FC) is a type of functional bowel disease that is in Clinically characterized by dysportia, decreased frequency of bowel movements, or incomplete bowel movements in the absence of irritable bowel syndrome syndrome, at least 6 months before diagnosis, and symptoms within the last 3 months. At present, commonly used drugs include enema and suppositories, laxatives, microecological preparations, gastrointestinal motility drugs and other treatments. However, the effect is limited. Traditional Chinese medicine (TCM) treatment of FC has advantages.

In this randomized controlled study, 244 eligible patients were randomly assigned in a 1:1 ratio to a treatment group (Zangfu ointment and massage therapy + Lactulose Oral Liquid) and a control group (Lactulose Oral Liquid) for 14 days. Number of spontaneous defecation per week and First defecation time will be used as primary outcomes, and Traditional Chinese Medicine (TCM) syndrome scores and syndrome scores,PAC-QOL form will be used as secondary outcomes. Blood routine, liver function, and renal function will be used as safety outcomes. The primary and secondary outcomes will be performed at 0th, 7th, and 14th day, and the safety outcomes will be performed at 0th and 14th day.

Ethical approval has been obtained from the Committee on Health Research Ethics of the Fangshan Hospital, Beijing University of Chinese Medicine, Beijing, People's Republic of China (FZY LK-2020-010) on September 18, 2020. All patients will be provided oral and written information about the trial before screening. The study results will be disseminated by peer-review publications and conference presentations.

ChiCTR2000038754 (registered on April 14, 2021).

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(1) The efficacy of the Zangfu ointment and massage therapy is evaluated in a randomised, double-blind 2-week clinical trial in FC patients.

(2) Form a complete and generalizable regimen for the treatment of FC (Qi stagnation) with the Zangfu ointment and massage therapy